A fixed-dose combination nasal spray containing a potent synthetic corticosteroid (Fluticasone Propionate) and a second-generation H1-antihistamine (Azelastine Hydrochloride). This combination provides dual-action anti-inflammatory and anti-allergic effects, offering superior symptom control for allergic rhinitis compared to monotherapy. It is indicated for moderate-to-severe seasonal and perennial allergic rhinitis in patients inadequately controlled by intranasal corticosteroids or antihistamines alone.
Adult: 1 spray (27.5 mcg Fluticasone + 140 mcg Azelastine) per nostril, twice daily. May reduce to once daily after symptoms are controlled.
Note: 1. Shake the bottle gently. 2. Prime the pump before first use or if unused for 7+ days by spraying into air until a fine mist appears. 3. Blow nose gently to clear nostrils. 4. Tilt head slightly forward. 5. Insert nozzle into nostril, pointing slightly away from nasal septum. 6. Close the other nostril with finger. 7. Activate spray while breathing in gently through the nose. 8. Repeat for other nostril. 9. Avoid blowing nose for 15 minutes. Clean nozzle weekly.
The combination exerts a synergistic effect through complementary pathways. Fluticasone propionate inhibits multiple inflammatory cells (mast cells, eosinophils, basophils, lymphocytes, macrophages) and mediators (histamine, eicosanoids, leukotrienes, cytokines). It reduces mucosal inflammation, hyperreactivity, and vascular permeability. Azelastine competitively and reversibly blocks histamine at H1-receptors, inhibiting the immediate allergic response. It also exhibits anti-inflammatory properties by inhibiting the release of histamine and other mediators from mast cells, and downregulating ICAM-1 expression.
Pregnancy: Category C (US FDA). Fluticasone: Animal studies show fetal harm; no adequate human studies. Azelastine: Animal studies show no risk; human data insufficient. Use only if potential benefit justifies potential fetal risk. Intranasal route minimizes systemic exposure.
Driving: May cause drowsiness, dizziness, or blurred vision (azelastine effect). Patients should not drive or operate machinery until they know how the medication affects them.
| Ketoconazole, Itraconazole, Ritonavir, other potent CYP3A4 Inhibitors | May significantly increase systemic exposure to fluticasone, increasing risk of systemic corticosteroid effects (Cushing's, adrenal suppression). | Major |
| Central Nervous System Depressants (Alcohol, Benzodiazepines, Opioids) | Azelastine may have additive sedative effects. | Moderate |
| Other Antihistamines (Oral) | Additive anticholinergic effects (dry mouth, urinary retention) and sedation. | Moderate |
| Other Nasal Corticosteroids | Increased risk of local side effects (irritation, septal perforation). | Moderate |
Same composition (Fluticasone Propionate (27.5mcg) + Azelastine (140mcg)), different brands: